Posted
by
ScuttleMonkey
on Friday January 22, 2010 @06:04PM
from the db-mavericks-unite dept.

An anonymous reader writes "The OMOP Cup is a competition to find new methods for detecting drug side effects. There have been several cases over the last few years where drugs have had issues that haven't been detected for years after they were released. The proliferation of electronic medical records and pharmacy claims provides a large and potentially powerful new data source for faster detection. The problem is that the techniques for doing this on a large scale are immature. The OMOP Cup is trying to help fix that. They've already given out $5,000 for top methods, and there's $15,000 still up for grabs."

I'm curious as to what proportion of medical records were incorrect and what proportion of pharmacy claims were inaccurate. Just how useful could a database like this be, if its source data is prone to some really wacky error? Side effect misdiagnoses alone could make for a considerable slog through noise just to pick up an effect.

Not very much money when you consider the amount of money that gets paid out to plaintiffs in lawsuits filed over drug side effects, such as the ones concerning Vioxx. This whole thing sounds a lot like the pharmaceutical companies are looking for a cheap fix, an alternative to the extensive drug trials they ought to be doing.

And then you *do* extensive drug trials, and people start complaining about how you torture animals, or how the price of the medicine is too high when it's finally on the market, or why they can't get the medicine while it's still in trial even though they don't fit the trial profile *at all* but it would save their kids life etc etc.

I still dont understand why the FDA does not allow drugs that have not been certified to be administered to terminal patients. There is no additional risk from doing it.

If the government respected a citizen's right to determine what will and won't be put into their own body, we would have never had a War on Drugs. What you mention there is just a logical extension of the idea that none of us can be trusted with the slightest degree of self-determination, not even when it cannot impact the lives of others.

"I still dont understand why the FDA does not allow drugs that have not been certified to be administered to terminal patients. There is no additional risk from doing it."
Because then there's no reason for companies to do trials, and you'll only have "we don't know if they work, but we sell them anyway" drugs. You'll also have all kinds of snake oil salesmen, which you don't want in a life-or-death situation. Rationality tends to break down in extreme situations.

Dig through a huge dataset like this looking for problems and you will find them. For everything. And with the FDA and court's approach, that means that even tiny effects will end up getting drugs knocked off the market. The COX-2 inhibitors are a perfect example. Sure, for a tiny number of people taking them they increased the risk of heart attack. But for untold numbers of people taking them, they relieved pain either where nothing else would, or with far fewer side effects than other pain medications like opoids. But in today's society, we're not allowed to trade a tiny risk of death versus an enormous chance of pain relief. So even the very tiny risks one can find this way will end up getting whole classes of non-lifesaving drugs off the market. No more analgesics, no more antihistamines, no more decongestants (oh, wait, they already virtually banned those for the War on Drugs), no more cough medicines, etc.

Datamining by Kaiser Permanente helped find a previously unknown risk of heart attack for certain users of VIOXX [wikipedia.org], and it was probably right that the drug was withdrawn. It may also be a good idea to re-approve it for those who would benefit with minimal risk. But without the post-approval datamining we would never know what the risk/benefit truly was.

That also points to some limitations of our drug approval process. Trial patients are followed only for so long. In fact, some of the trial patients who we

If you believe in the science that brings you modern medicine to begin with, then more knowledge is always better.

It's not the science I object to; it's the politics. The Vioxx study, subsequent FDA action, and subsequent lawsuits resulted in nearly every COX-2 inhibitor being taken off and kept off the market, despite the tiny magnitude of the risks. Given that, I think it's better to not seek out knowledge of such small risks rather than risk that kind of overreaction.

This strikes me as a huuuuuge breach of medical record confidentiality. Where exactly do they plan to legally get enough medical records to mine in the first place?

As long as eighteen HIPAA identifiers are removed, the data is considered deidentified by HIPAA. Deidentified data does not need patients' consent. De-identified data-only studies only need the hospital IRB (Institutional Review Board) approval. Believe me, it's not an easy task to get the IRB approval.

As long as eighteen HIPAA identifiers are removed, the data is considered deidentified by HIPAA. Deidentified data does not need patients' consent. De-identified data-only studies only need the hospital IRB (Institutional Review Board) approval. Believe me, it's not an easy task to get the IRB approval.

If the data-set has been completely de-identified (with the actual dates of all events truncated/obfuscated), or otherwise meets the criteria defined under the HIPAA Safe Harbor de-identification [utah.edu] method, then it is not considered to be a HIPAA violation.

I could focus on reducing mortality due to prescription drug side-effects and maybe get $5k? That's awesome, I can totally help out my fellow... what's that? I get $1M if I rock NetFlix's movie rating DB? Movie ratings here I come!

They've already given out $5,000 for top methods, and there's $15,000 still up for grabs.

Whoa there, big spender! I'm all for serving the public good, but if I was to work all those extra hours and discovered a useful new technique for using this data, and I have to choose between maybe getting somewhat less than what I still owe on my car, or trying to sell the code to the deep pockets of Big Pharma, I know which one I'm going to go with.

They've already given out $5,000 for top methods, and there's $15,000 still up for grabs.

Whoa there, big spender! I'm all for serving the public good, but if I was to work all those extra hours and discovered a useful new technique for using this data, and I have to choose between maybe getting somewhat less than what I still owe on my car, or trying to sell the code to the deep pockets of Big Pharma, I know which one I'm going to go with.

Can't disagree there, but I wanted to point out you probably want to sell this to class action attorneys for the real money. Pharmaceutical companies will bury this quicker than you can sign over the rights to it.

The base assumption of this seems to be, that the point of a pharma company is to heal people with safe drugs.

It’s not. In fact, if they don’t lose money from it, it is completely irrelevant if you die a slow and horrible death.Proven by many, many products that are out there right now. Like Prozac. It does help nobody. In fact it does the exact opposite, because it drives people even further into repression. And therefore dependency on the stuff.

The base assumption of this seems to be, that the point of a pharma company is to heal people with safe drugs.

It’s not. In fact, if they don’t lose money from it, it is completely irrelevant if you die a slow and horrible death.Proven by many, many products that are out there right now. Like Prozac. It does help nobody. In fact it does the exact opposite, because it drives people even further into repression. And therefore dependency on the stuff.

The point of pharma companies, is to make money.As long as that is not 100% and without any loopholes, tied to what we want from them,we will have no guarantee at all to get it.

If the government collaborate with drug companies and you are legally drugged, there is hardly any hope for mankind. I do understand from a friend in the USA that some kids are legally drugged with psychiatric drugs namely Ritalin and it has gone one step further that unless you receive shots, kids are not allowed to attend school.
We have so far resisted part of this in the UK, but the drug companies and government is trying to weasel they're way around it. I also have something to say about Gulf War Synd